510(k) K822870

STOOL-COLLECTION/PRESERVATION KIT by American Scientific Products — Product Code KDT

K822870 is an FDA 510(k) premarket notification submitted by American Scientific Products for the device "STOOL-COLLECTION/PRESERVATION KIT". The FDA issued a decision of Substantially Equivalent on November 1, 1982. The device falls under product code KDT (Container, Specimen Mailer And Storage, Sterile), a Class I device regulated under 21 CFR 864.3250. American Scientific Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1982
Date Received
September 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Specimen Mailer And Storage, Sterile
Device Class
Class I
Regulation Number
864.3250
Review Panel
PA
Submission Type